1. Pink Sheet

Keeping Track: Accelerated Approval For Tecentriq And A Burst Of Filings And Submissions

 
• By Michael Cipriano

The latest drug development news and highlights from our US FDA Performance Tracker. 

Keeping Track Feature image

Drugmakers and the US FDA produced another tsunami of drug development news last week, and some of it was too big to fit into this edition. So don't miss our coverage of two breakthrough therapy designations being rescinded (see sidebar), as well as a Genentech Inc. supplemental new drug application (sNDA) submission under the Real-Time Oncology Review (RTOR) pilot program (more on that in a subsequent issue of the Pink Sheet).

Here's the rest of your news in brief:

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Product Reviews

More from Pink Sheet

Sponsors Asked, EMA Delivered: One Handbook To Navigate CTIS

 
• By Vibha Sharma

The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.

Will Tidmarsh’s Industry Experience Translate As US FDA’s Chief Drug Regulator?

 
• By Sarah Karlin-Smith and Derrick Gingery

The long-time industry executive led several drug approvals but may have a lot to learn about the intimate details of application review and the Center for Drug Evaluation and Research.

Don’t Look Back: US FDA AdComm Offers No Flexibility For Rexulti’s Post Hoc Bid In PTSD

 
• By Bridget Silverman

The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.